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Merck makes beeline to FDA, seeking approval for COVID-19 antiviral 10 days after reporting data

October 11, 2021


Merck isn’t hanging around. Ten days after reporting data on its oral COVID-19 antiviral molnupiravir, Merck has filed for emergency use authorization from the FDA as part of a rapid global push to get the drug to patients.

Oct. 1, Merck and its partner Ridgeback Biotherapeutics reported that molnupiravir halved the risk of hospitalization and death in a phase 3 clinical trial. No patients died in the molnupiravir arm, compared to eight deaths in the placebo group. With the U.S. averaging 1,600 to 2,000 deaths a day in recent weeks, the results suggest molnupiravir can have a significant impact, driving Merck to act fast.

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